Nextstellis® Receives FDA Marketing Exclusivity And Phase III Data Published

27 May 2021, 07:30 CEST – Adelaide, Australia and Liege, Belgium – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the novel oral contraceptive Estelle® – under the trademark Nextstellis® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) – has been granted marketing exclusivity as a new chemical entity (NCE) from the US Food and Drug Administration (FDA). The exclusivity runs for five years from FDA approval of the New Drug Application for Nextstellis.

Mithra Announces European Approval of Estelle®

Liege, Belgium, 20 May 2021 –18:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is very pleased to announce that the European Commission has accepted the registration application for the novel combined oral contraceptive Estelle®. This decision follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) on 26 March 2021 and is valid for all Member States of the European Union.

Mithra’s General Meeting of Shareholders Approves the Renewal of its Board of Directors

Liege, Belgium, 20 May 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today held its Annual General Meeting of securities holders. All agenda items put to vote were approved, including the appointment of Directors for a two-year-mandate.

 

Information on the Total Number of Voting Rights (Denominator)

Liege, Belgium, 6 May 2021 – 17:45 CEST – In accordance with article 15 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions, Mithra Pharmaceuticals SA (the “Company” or “Mithra”) announces the below information, following the issuance of 1,023,000 new shares on May 6, 2021 for a total amount of EUR 3,500,520 as the result of the exercise of 620 subscription rights (warrants) pursuant to the warrant plan initiated on March 2, 2015.